MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381137
Medical Device Problem Codes	Packaging Problem (3007); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Characters limit is exceeded: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd angiocath package open seal / sterility concern the following information was provided by the initial reporter: the hospital reported that when the second cannula was used, the packaging of the third cannula was also torn off.The hospital felt that the problem was caused by the packaging not being tightly sealed and the plastic not being cut.There were two cannulas, and the samples could not be returned.Photos can be provided.A green claim is required, and a complaint response letter and receipt letter are required.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381137 and lot number 4257586.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, the packaging appears to be torn.According to the lot history analysis, the adhesive transfer test (to verify week/strong sealing), the leakage test, and the picot test (which consists of verifying whether the cut is correct and the number of picots are consistent across the cavities) were all found to be within specifications.Based on the information provided, the packaging tore during use of the product.An exact cause for this incident could not be determined.As stated in the instructions for use: ¿inspect the unit packaging before opening to confirm its integrity.Caution: do not use if the packaging is damaged or opened, or if the expiration date has passed.¿ at this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22407372
• Report Number: 9610048-2025-00089
• Device Sequence Number: 12831435
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)241025(17)290930(10)4257586
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381137
• Device Lot Number: 4257586
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/05/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown